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Anti-gingivitis Mouthrinse

Primary Purpose

Gingivitis

Status
Not yet recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Amine/zinc lactate/fluoride system
negative control
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Availability for the six-month duration of the clinical research study. Good general health. Minimum of 20 uncrowned permanent natural teeth (excluding third molars). Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967). Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970). Signed Informed Consent Form. Exclusion Criteria: Presence of orthodontic bands. Malign tumor(s) of the soft or hard tissues of the oral cavity. Antibiotic use any time during the one-month period prior to entry into the study. Participation in any other clinical study or test panel within the one month prior to entry into the study. Dental prophylaxis during the past two weeks prior to baseline examinations. History of allergies to oral care/personal care consumer products or their ingredients. On any prescription medicines that might interfere with the study outcome. An existing medical condition that prohibits eating or drinking for periods up to 4 hours. History of alcohol or drug abuse. Self-reported pregnant or lactating subjects. Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics). Participants who require antibiotic treatments for dental appointments. Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3). Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa); Smokers or/and users of tobacco products. Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)

Sites / Locations

  • Technische Universität Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mouthwash Test

Mouthwash Experimental

Arm Description

Outcomes

Primary Outcome Measures

Whole-mouth Mean Modified Gingival Index (MGI)
Gingivitis, gingival severity and gingival, interproximal scores as measured by the Gingival Index (Löe 1967) as difference from baseline to 24 weeks between the study groups.

Secondary Outcome Measures

Turesky Modification of the Quigley Hein Plaque Index (PI)
Plaque, plaque severity and plaque interproximal scores as measured by the Plaque Index (Turesky et al. 1970) as difference from baseline to 24 weeks between the study groups and at each time-point.
Intraoral scans
Quantitative changes & before/after imagery from intraoral scans
Patient-reported experiences
Changes in participant-reported experience as determined through participant-questionnaire

Full Information

First Posted
September 16, 2023
Last Updated
October 18, 2023
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT06048627
Brief Title
Anti-gingivitis Mouthrinse
Official Title
Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and Gingivitis: a 6-month Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mouthwash Test
Arm Type
Active Comparator
Arm Title
Mouthwash Experimental
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Amine/zinc lactate/fluoride system
Intervention Description
Amine/zinc lactate/fluoride system (250 ppm F), meridol®, Colgate-Palmolive
Intervention Type
Drug
Intervention Name(s)
negative control
Intervention Description
Sodium fluoride mouthwash 250 ppm
Primary Outcome Measure Information:
Title
Whole-mouth Mean Modified Gingival Index (MGI)
Description
Gingivitis, gingival severity and gingival, interproximal scores as measured by the Gingival Index (Löe 1967) as difference from baseline to 24 weeks between the study groups.
Time Frame
Baseline, 3 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Turesky Modification of the Quigley Hein Plaque Index (PI)
Description
Plaque, plaque severity and plaque interproximal scores as measured by the Plaque Index (Turesky et al. 1970) as difference from baseline to 24 weeks between the study groups and at each time-point.
Time Frame
Baseline, 3 weeks, 12 weeks, 24 weeks
Title
Intraoral scans
Description
Quantitative changes & before/after imagery from intraoral scans
Time Frame
Baseline, 3 weeks, 12 weeks, 24 weeks
Title
Patient-reported experiences
Description
Changes in participant-reported experience as determined through participant-questionnaire
Time Frame
Baseline, 3 weeks, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Availability for the six-month duration of the clinical research study. Good general health. Minimum of 20 uncrowned permanent natural teeth (excluding third molars). Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967). Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970). Signed Informed Consent Form. Exclusion Criteria: Presence of orthodontic bands. Malign tumor(s) of the soft or hard tissues of the oral cavity. Antibiotic use any time during the one-month period prior to entry into the study. Participation in any other clinical study or test panel within the one month prior to entry into the study. Dental prophylaxis during the past two weeks prior to baseline examinations. History of allergies to oral care/personal care consumer products or their ingredients. On any prescription medicines that might interfere with the study outcome. An existing medical condition that prohibits eating or drinking for periods up to 4 hours. History of alcohol or drug abuse. Self-reported pregnant or lactating subjects. Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics). Participants who require antibiotic treatments for dental appointments. Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3). Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa); Smokers or/and users of tobacco products. Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrin Lorenz, Dr
Phone
493514585938
Email
katrin.lorenz@ukdd.de
Facility Information:
Facility Name
Technische Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrin Lorenz
Phone
+493514585938
Email
katrin.lorenz@ukdd.de
First Name & Middle Initial & Last Name & Degree
Barbara Noack
Phone
493514582712
Email
barbara.noack@ukss.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Anti-gingivitis Mouthrinse

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